CENTRALSCOPE 12— 510(k) K901072
Substantially EquivalentMarquette Electronics, Inc.
FDA 510(k) clearance K901072 for CENTRALSCOPE 12, Substantially Equivalent on 1990-08-23. Applicant: Marquette Electronics, Inc.. Device class: 2.
Clearance details
- Applicant
- Marquette Electronics, Inc.
- Product code
- Product code DXJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.2450
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Milwaukee, WI, US
Recent devices under product code DXJ
view all- K261469 — Nexxis 2; Nexxis OR 2; NMS 2; MNA-240; MNA-4x0 (Where x may be any numeric character).
- K212003 — ESSENZ Patient Monitor
- K212208 — Philips IntelliVue GuardianSoftware (Rev. E.0X)
- K201162 — Essence 55SP Large Monitor System
- K173107 — Vios Central Station Monitor Software, Vios Central Server Software
More clearances from Marquette Electronics, Inc.
view allAdverse events under product code DXJ
product code DXJ- Death
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.